CurrentUnitedHealthcarePolicy 2024D0082G

Krystexxa (Pegloticase) — Coverage Criteria

Defines medical necessity and coverage criteria for use of Krystexxa (pegloticase) to treat chronic gout refractory to conventional therapy for UnitedHealthcare members, including initial and continuation authorization requirements and applicable billing codes.

Policy Summary

PayerUnitedHealthcare

PolicyKrystexxa (Pegloticase) — Coverage Criteria

Policy CodePolicy 2024D0082G

Change TypeNo material change

Effective DateNov 1, 2024

Next Review Date

Key ActionObtain prior authorization with documentation of symptomatic chronic gout and trials of allopurinol and febuxostat (or documented intolerance/contraindication) and submit baseline serum uric acid >6 mg/dL with ongoing pre-infusion monitoring.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J2507HCPCS code

>=2flares criterion

<6 mg/dLsUA target

12 moapproval period

refractory goutFDA indication

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Coverage Criteria for Krystexxa (pegloticase)

Initial Therapy

Covered when ALL of the following are met:

Initial therapy requirements: 1) Diagnosis of symptomatic gout defined by at least one of the following: history of ≥2 gout flares in the previous 12 months; at least 1 gouty tophus; or chronic gouty arthropathy; AND 2) Documented history of contraindication, intolerance, or treatment failure (failure to normalize serum uric acid to < 6 mg/dL after ≥3 months of therapy at the maximally medically appropriate dose) with BOTH allopurinol (Zyloprim) and febuxostat (Uloric); AND 3) Baseline serum uric acid level > 6 mg/dL documented by laboratory values; AND 4) Prescriber attests that serum uric acid levels will be monitored prior to each infusion and that discontinuation will be considered if preinfusion levels increase above 6 mg/dL; AND 5) Prescribed by a rheumatologist or nephrologist; AND 6) Krystexxa is initiated and titrated according to US FDA labeled dosing for chronic gout; AND 7) Initial authorization will be for no more than 12 months.> 6 mg/dL baseline required

Preservation of CMS/Medicare-specific review language where applicable

Continuation Therapy

Covered when ALL of the following are met:

Continuation requirements: 1) Patient has previously received Krystexxa; AND 2) Patient experienced a positive clinical response to Krystexxa (for example, serum uric acid < 6 mg/dL or reduction in tophus); AND 3) Patient has not had two consecutive serum uric acid measurements > 6 mg/dL after initiating treatment with Krystexxa; AND 4) Prescribed by a rheumatologist or nephrologist; AND 5) Krystexxa continued per US FDA labeled dosing for chronic gout; AND 6) Reauthorization will be for no more than 12 months.serum uric acid < 6 mg/dL indicates response; two consecutive > 6 mg/dL is a stoppage trigger

Continuation requires clinical benefit and ongoing specialty prescriber

Not medically necessary

Unproven/Not Medically Necessary: Krystexxa (pegloticase) is unproven and not medically necessary for the treatment of asymptomatic hyperuricemia.

Limitation of use per policy

Initial therapy / Medical necessity

Covered when ALL of the following are met

Eligibility: 1) Adult patient with chronic gout (per FDA definition: chronic gout refractory to conventional therapy); AND 2) Disease refractory to conventional therapy defined as failure to normalize serum uric acid and signs/symptoms inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated; AND 3) Clinical features warranting pegloticase, such as frequent gout flares (≥2 flares/year), nonresolving subcutaneous tophi, or severe debilitating chronic tophaceous gout adversely affecting quality of life; AND 4) Prior trials of appropriate ULT (xanthine oxidase inhibitors and, where appropriate, uricosurics) have failed to achieve the serum uric acid target or were not tolerated/contraindicated; AND 5) Provider documents supportive clinical rationale and relevant prior therapy, dosing, and duration; AND 6) Serum uric acid monitoring and other management per specialty guidance (ACR/EULAR) and prescriber agreement to discontinue if preinfusion uric acid rises above 6 mg/dL.flares >= 2/year for consideration; failure to achieve SUA < 6 mg/dL defines refractory disease

Reflects FDA indication and ACR/EULAR recommendations for consideration of pegloticase

Krystexxa (pegloticase) is unproven and not medically necessary for the treatment of asymptomatic hyperuricemia.

Use of Krystexxa for asymptomatic hyperuricemia is a limitation of use and is excluded; Krystexxa is not recommended for this indication.

Krystexxa is considered not medically necessary when requested for asymptomatic hyperuricemia.

Coding and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J2507

Injection, Pegloticase, 1mg

Covered ICD-10 Diagnosis Codes (sample listing)ICD-10

M1A.0390	Idiopathic chronic gout, unspecified wrist, without tophus (tophi).
M1A.0391	Idiopathic chronic gout, unspecified wrist, with tophus (tophi).
M1A.0410	Idiopathic chronic gout, right hand, without tophus (tophi).
M1A.0411	Idiopathic chronic gout, right hand, with tophus (tophi).
M1A.0420	Idiopathic chronic gout, left hand, without tophus (tophi).
M1A.0421	Idiopathic chronic gout, left hand, with tophus (tophi).
M1A.0490	Idiopathic chronic gout, unspecified hand, without tophus (tophi).
M1A.0491	Idiopathic chronic gout, unspecified hand, with tophus (tophi).
M1A.0510	Idiopathic chronic gout, right hip, without tophus (tophi).
M1A.0511	Idiopathic chronic gout, right hip, with tophus (tophi).

Applicable ICD-10 Diagnosis CodesICD-10

M1A.3511	Chronic gout due to renal impairment, right hip, with tophus (tophi)
M1A.3520	Chronic gout due to renal impairment, left hip, without tophus (tophi)
M1A.3590	Chronic gout due to renal impairment, unspecified hip, without tophus (tophi)
M1A.3610	Chronic gout due to renal impairment, right knee, without tophus (tophi)
M1A.3611	Chronic gout due to renal impairment, right knee, with tophus (tophi)
M1A.3690	Chronic gout due to renal impairment, unspecified knee, without tophus (tophi)
M1A.3691	Chronic gout due to renal impairment, unspecified knee, with tophus (tophi)
M1A.3710	Chronic gout due to renal impairment, right ankle and foot, without tophus (tophi)
M1A.3711	Chronic gout due to renal impairment, right ankle and foot, with tophus (tophi)
M1A.3720	Chronic gout due to renal impairment, left ankle and foot, without tophus (tophi)

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Serum uric acid level — baseline and treatment response thresholds

Baseline requirementBaseline serum uric acid level > 6 mg/dL is required prior to initiation of Krystexxa.

Treatment response targetSuccessful response defined as normalization of serum uric acid to < 6 mg/dL (example of positive clinical response).

Monitoring requirementPrescriber must attest that serum uric acid levels will be monitored prior to each infusion; consider discontinuation if pre‑infusion levels increase above 6 mg/dL.

Continuation thresholdPatient must not have two consecutive uric acid levels > 6 mg/dL after initiating Krystexxa to remain eligible for continuation.

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation and continuation of Krystexxa (pegloticase) for chronic gout. Initial authorizations are limited to a maximum of 12 months; reauthorizations (continuation) are also limited to no more than 12 months. Prescriptions must be by a rheumatologist or nephrologist and dosing must follow FDA labeling.

Initial authorization: up to 12 months
Reauthorization: up to 12 months
Prescriber: Rheumatologist or Nephrologist
Dosing: initiated and titrated per US FDA labeling

Documentation Required

Diagnosis and Prior Therapy Documentation

Documented diagnosis and prior therapy history must be submitted to support medical necessity for pegloticase. For Medicare reviews, follow applicable CMS guidance where indicated.

Background and Scope

Krystexxa (pegloticase) is indicated for the treatment of chronic gout refractory to conventional therapy. The policy covers Krystexxa only for adult patients who meet diagnostic and documentation requirements for symptomatic chronic gout and who have failed or are intolerant/contraindicated to xanthine oxidase inhibitor therapy. Prior authorization is required and initial approval is limited to up to 12 months; baseline serum uric acid must be > 6 mg/dL and prescribers must monitor uric acid prior to each infusion and consider discontinuation if preinfusion levels rise above 6 mg/dL.

Definitions and Policy Terms

Symptomatic gout — definition

DefinitionSymptomatic gout is defined as history of at least 2 gout flares in the previous 12 months, or at least 1 gouty tophus, or chronic gouty arthropathy.

Documentation neededClinical documentation should support diagnosis (e.g., records of flares, tophus identification, or imaging/notes demonstrating chronic gouty arthropathy).

Treatment failure — definition

DefinitionTreatment failure is failure to normalize serum uric acid to < 6 mg/dL after 3 months of therapy at the maximally medically appropriate dose of allopurinol and febuxostat.

Required prior therapiesFailure must be documented for BOTH Zyloprim (allopurinol) and Uloric (febuxostat) at maximally appropriate dosing for ≥3 months.

Impact on authorization